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FDA names former pharmaceutical company executive to oversee US drug program
The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency. FDA Commissioner ...
BioSpace13d
FDA Opens Pilot Run of Commissioner Voucher Program
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
PharmExec13d
FDA Appoints George Tidmarsh as Director of Center for Drug Evaluation and Research
Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...
BioPharma Dive6d
Vinay Prasad’s ouster leaves biotech guessing at FDA direction
The abrupt exit of the former CBER director raises questions about the FDA’s leadership. For now, newly appointed CDER head ...
kcra.com1mon
FDA launches program for faster drug reviews - KCRA Channel 3
FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.